Using antibiotics to prevent bladder infections after Botox treatment
Prophylactic Antibiotics During Treatment of Idiopathic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial
This study is testing if taking antibiotics after Botox treatment can help prevent bladder infections in women with overactive bladder.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04444440 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of prophylactic antibiotics, specifically Ciprofloxacin, in reducing postoperative bladder infections following Botox injections for idiopathic overactive bladder in women. Participants will be randomly assigned to receive either the antibiotic or a placebo for three days after the procedure. The study will monitor the incidence of bladder infections and any side effects over a six-week follow-up period. Urine cultures will be collected to confirm infections, and a questionnaire will assess urinary symptoms and adverse events.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with idiopathic overactive bladder who have not responded to medical management.
Not a fit: Patients with neurogenic overactive bladder, those currently on antibiotics, or males will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative bladder infections in women undergoing Botox treatment for overactive bladder.
How similar studies have performed: While the use of prophylactic antibiotics in similar surgical contexts has shown promise, this specific approach for Botox treatment in overactive bladder is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with idiopathic OAB diagnosed clinically who have failed medical management * Female * Age ≥ 18 Exclusion Criteria: * Patients with neurogenic OAB (OAB with potential underlying neurologic cause - multiple sclerosis, spinal cord injury, Parkinson's disease, other) * Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, current urinary tract infection, symptomatic urinary retention or PVR \> 200 mL, unwillingness or inability to initiate CIC post-treatment if required. * Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14 * Active antibiotic therapy for any indication at the time of Botox injection - increased risk of adverse reaction with combining antibiotics, reduced risk of UTI with additional antibiotic. * Male * Age \< 18 * Pregnant and/or breastfeeding
Where this trial is running
Edmonton, Alberta
- Urogynecology Clinic - Royal Alexandra Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Erin Kelly, MD FRCSC
- Email: eckelly@ualberta.ca
- Phone: 780-735-5290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.